ACETAMINOPHEN
- Product NDC
- 68071-3959
- 11-digit product format
- 680713959
- Labeler code
- 68071
- Product ID
- 68071-3959_49660efe-1322-6942-e063-6294a90a0686
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-02-15
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACETAMINOPHEN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4965fc33-f815-d49e-e063-6394a90a119c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3959-1 | ACETAMINOPHEN | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 68071-3959-1 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET | 100 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 0faa3592-4d56-4645-9a0e-066e0bdfebb6 | 2024-04-05 | Warnings | M013 |
| Pain Relief Childrens Dye Free | ACETAMINOPHEN | H E B | 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9 | 2024-04-03 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | H E B | edb321dd-e5cb-4031-a8a8-efce9e86fe16 | 2024-04-03 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | H E B | a0c0277e-50aa-4328-8f93-ab20c6176b2b | 2024-04-03 | Warnings | M013 |
| Regular Strength Enteric coated aspirin | ASPIRIN | Bryant Ranch Prepack | bda805ab-7f37-405d-a144-4e06ad9a29a1 | 2024-04-03 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Family Dollar (FAMILY WELLNESS) | 650cb15e-c448-4df3-b0f8-4398be05d841 | 2024-03-27 | Warnings | M013 |
| Good Sense Effervescent Pain Relief | ASPIRIN | Perrigo Direct, Inc. | 103027a7-2f0e-8d8c-e063-6294a90aedc7 | 2024-03-26 | Warnings | M013 |
| rugby infants acetaminophen | ACETAMINOPHEN | Rugby Laboratories | 8aa9ac68-ca61-4163-a876-52034138c1ea | 2024-03-25 | Warnings | M013 |
| Equate Pain Reliever Acetaminophen for Adults 250 mg | ACETAMINOPHEN | Walmart Inc | 08a18481-f029-f01f-e063-6294a90aac65 | 2024-03-21 | Warnings | M013 |
| Equate Pain Reliever Acetaminophen for Adults 250 mg | ACETAMINOPHEN | Walmart Inc | 0d106fa2-2a77-deb2-e063-6394a90a2dac | 2024-03-21 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 872c5220-a379-4dc1-b99c-f11ebb82db35 | 2024-03-19 | Warnings | M013 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 79886972-47a4-44c5-a131-1a691a328103 | 2024-03-19 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 5ffcc78d-9163-4cb4-8811-ae9f0142806a | 2024-03-18 | Warnings | M013 |
| ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER | ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER | HF Acquisition Co LLC, DBA HealthFirst | 13e621dc-b2b4-98fd-e063-6394a90acc75 | 2024-03-17 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS PHARMACY, INC | 097a9c98-a092-400d-9600-6797b0b9a50c | 2024-03-15 | Warnings | M013 |
| Excedrin PM Triple Action Caplets and Excedrin Tension Headache | ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE | Haleon US Holdings LLC | 978a9d27-6d41-42cb-a193-11314923d2ac | 2024-03-14 | Warnings | M013 |
| Excedrin PM Triple Action Caplets | ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE | Haleon US Holdings LLC | b3812d27-40af-40d7-864a-dfa4ae34cb9e | 2024-03-14 | Warnings | M013 |
| Excedrin Extra Strength Pain Reliever | ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE | Haleon US Holdings LLC | 691b754c-bafc-47e2-a322-cf56245c01f6 | 2024-03-14 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS PHARMACY, INC | fdc80b2a-d7c1-4b3d-9a9b-28182c6320de | 2024-03-14 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 2cde052d-22a4-470f-8d6a-7c17061b8ac8 | 2024-03-14 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 4965fc33-f815-d49e-e063-6394a90a119c | 1 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 4965fc33-f815-d49e-e063-6394a90a119c | 1 |
| 198440 | APAP 500 MG Oral Tablet | SY | 4965fc33-f815-d49e-e063-6394a90a119c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68071-3959-1 | 68071395901 | 1 BOTTLE in 1 CARTON (68071-3959-1) / 100 TABLET in 1 BOTTLE | 1 bottle | 2026-01-27 | No | No | Current |